Regulatory Guide line For Central Administration For Biological , Innovation Products and clinical studies

Type	Issue date	Description	Issue date
Guide line	2022	Procedures for Registration of Biological products through Reliance pathways 2022	01
Guide line	2022	Good Review Practice Guideline	02
Guide line	2023	Guideline for Registration of Biosimilar Products in Egypt	04
Guide line	2023	Regulatory Guideline of the Registration Procedures of the Innovative Products	01
-	2023	Appendices of Regulatory Guideline of the Registration Procedures of the Innovative Product	01
Guide line	2023	GUIDELINE ON Content File of Biological Products for Registration & Re-registration file	03
Guide line	2023	Appendices of Regulatory Guideline of the Registration Procedures of the Innovative Products
Guide line	04/2023	Guidelines on emergency use approval	04
Guide line	12/2023	Guideline on the regulation of Post-approval changes to a registered Bio therapeutic products	01
Guide line	05/2024	Guideline on E-Labelling of Medical Leaflets of Medicinal Products for Human Use	02
Guide line	07/2024	Guideline for Post Market Quality Monitoring of Biological Products in Egypt	01
Guide line	09/2024	Guideline for Good Regulatory Oversight of Clinical Trials by Egyptian Drug Authority	03
Guide line	09/2024	Guideline for Lot Release of Biological Products in Egypt	02
Guide line	09/2024	Regulatory Guideline of Mechanisms and Rules of Implementing the Decree of Egyptian Drug Authority's Chairman No. (343) of 2021	03
Guide line	10/2024	Guideline for Preclinical testing and Clinical Investigation for Medical devices	01
Guide line	11/2024	Guideline for File Content of Biological Products for Registration & Re-registration file	04

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Regulatory Guidelines

Regulatory Guide line For Central Administration For Biological , Innovation Products and clinical studies